An Investigational Drug for the Prevention of Chemotherapy-Induced Nausea and Vomiting (MK-0869-071)

A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092183

Enrollment

866

Registered

2004-09-24

Start date

2002-10-10

Completion date

2004-02-11

Last updated

2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Nausea, Vomiting

Keywords

Chemotherapy-Induced Nausea and Vomiting

Brief summary

This protocol will study an investigational drug treatment plan against standard therapy in the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic chemotherapy.

Interventions

DRUGMK0869, aprepitant / Duration of Treatment: 3 days

DRUGComparator: ondansetron / Duration of Treatment: 3 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy.

Exclusion criteria

* Patient has a central nervous system malignancy. * Patient will receive radiation to the abdomen or pelvis.

Design outcomes

Primary

Measure	Time frame
Emesis and use of rescue medication	—
Safety and tolerability	—

Secondary

Measure	Time frame
Quality of life	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026